The Effect of a Second Dose of Measles Vaccine at 18 Months of Age on Nonaccidental Deaths and Hospital Admissions in Guinea-Bissau: Interim Analysis of a Randomized Controlled Trial.

booster dose heterologous effects measles eradication measles vaccine non-specific effects of vaccines

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
12 10 2022
Historique:
received: 10 09 2020
pubmed: 27 2 2022
medline: 15 10 2022
entrez: 26 2 2022
Statut: ppublish

Résumé

The world is set on the eradication of measles. Continuation of the measles vaccine (MV) after eradication could still reduce morbidity because the MV has so-called beneficial nonspecific effects. We evaluated the effect of a "booster" dose of the MV on overall severe morbidity. We conducted a randomized controlled trial among children aged 17.5 to 48 months in Guinea-Bissau, where the MV is recommended only at 9 months of age. At the time of this interim analysis, 3164 children had been allocated 1:1 to a second dose of measles vaccine (MV2) at 18 months of age or to no vaccine. Severe morbidity (a composite outcome of nonaccidental deaths and hospital admissions) rate ratios (SMRRs) were calculated by Cox regression analysis censored for national oral polio vaccine (OPV) campaigns. There were no measles cases during the trial period. There were 43 nonaccidental deaths or hospital admissions during follow-up. Severe morbidity was 2.6 per 100 person-years in the MV2 group and 3.6 per 100 person-years among controls; hence, the estimated effect of MV2 on severe morbidity was 28% (SMRR, 0.72; 95% confidence interval [CI], .38-1.38). At 12 months of follow-up, the number needed to treat to prevent 1 severe morbidity event was 137 children. After OPV campaigns, the estimated effect of MV2 was reduced to 9% (SMRR, 0.91; 95% CI, .46-1.81). MV2 may reduce nonmeasles severe morbidity by 28% (-38% to 62%), although this did not achieve statistical significance in this study. If significant in higher powered studies, this has major implications for child health, even after measles eradication. NCT02943681.

Sections du résumé

BACKGROUND
The world is set on the eradication of measles. Continuation of the measles vaccine (MV) after eradication could still reduce morbidity because the MV has so-called beneficial nonspecific effects. We evaluated the effect of a "booster" dose of the MV on overall severe morbidity.
METHODS
We conducted a randomized controlled trial among children aged 17.5 to 48 months in Guinea-Bissau, where the MV is recommended only at 9 months of age. At the time of this interim analysis, 3164 children had been allocated 1:1 to a second dose of measles vaccine (MV2) at 18 months of age or to no vaccine. Severe morbidity (a composite outcome of nonaccidental deaths and hospital admissions) rate ratios (SMRRs) were calculated by Cox regression analysis censored for national oral polio vaccine (OPV) campaigns.
RESULTS
There were no measles cases during the trial period. There were 43 nonaccidental deaths or hospital admissions during follow-up. Severe morbidity was 2.6 per 100 person-years in the MV2 group and 3.6 per 100 person-years among controls; hence, the estimated effect of MV2 on severe morbidity was 28% (SMRR, 0.72; 95% confidence interval [CI], .38-1.38). At 12 months of follow-up, the number needed to treat to prevent 1 severe morbidity event was 137 children. After OPV campaigns, the estimated effect of MV2 was reduced to 9% (SMRR, 0.91; 95% CI, .46-1.81).
CONCLUSIONS
MV2 may reduce nonmeasles severe morbidity by 28% (-38% to 62%), although this did not achieve statistical significance in this study. If significant in higher powered studies, this has major implications for child health, even after measles eradication.
CLINICAL TRIALS REGISTRATION
NCT02943681.

Identifiants

pubmed: 35218356
pii: 6537530
doi: 10.1093/cid/ciac155
pmc: PMC9797043
doi:

Substances chimiques

Measles Vaccine 0
Poliovirus Vaccine, Oral 0

Banques de données

ClinicalTrials.gov
['NCT02943681']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1370-1378

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Déclaration de conflit d'intérêts

Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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Auteurs

Mike L T Berendsen (MLT)

Bandim Health Project, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.
Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Department of Internal Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.

Isaquel Silva (I)

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Carlitos Balé (C)

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Sebastian Nielsen (S)

Bandim Health Project, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.
Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Sophus Hvidt (S)

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Cesario L Martins (CL)

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Christine S Benn (CS)

Bandim Health Project, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.
Danish Institute for Advanced Study, University of Southern Denmark, Odense, Denmark.

Peter Aaby (P)

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

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